Data Management

Data management / web-based electronic Case Report Forms (eCRF)

Electronic Case Report Forms (eCRF) replaced the conventional paper forms, providing authorized users global availability independent of particular computer platforms. There is no need for installation of plug-ins or special software. The system is scalable and adaptable to study-specific technical requirements.

The user logs in with a personal username and password. The communication is SSL-encrypted. Instead of using paper forms, the investigator or a study nurse interactively fills in the electronic forms. The data are checked automatically for plausibility and completeness during data entry. Reactive alerts and helps assure correct completion. Pages can be saved incomplete or with questionable data as draft. After final checks they are finalized by the investigator.

Electronic Case Report Forms (eCRF) shorten the way of data-transmission from the clinical sites to the study center. Instead of filling in paper forms and later entering the data into the database, the data are remotely entered into the database, while being checked extensively. Therefore, a lot of misunderstanding, lacking or incorrect data can be avoided. This reduces the time from the source of the data to the validated storage in the database by weeks or months. Shortly after completion of the last study case the database can be locked and the evaluation will be done immediately. Finally, the eCRF minimizes the efforts necessary for performing clinical studies and correcting failures. This is true for the clinic as well as for monitoring.

The system traces each modification of the data in the database, to document day, time, and user who did enter or correct the data. In case of changes the original data remain visible.

Real Time Feedback is a major attainment of the Internet-based data collection. Due to the data being stored immediately in a database there is no delay for getting information on the progress of the study or the situation regarding adverse events (AEs). While scientific results should be drawn only from the final collection of all study data, status information can seriously improve trial management.

We're constantly improving the usability of the system based on the user feedback we get from the participants in our studies.

  • Web-based access to patient records, no local software
  • Access via SSL-connection, personal identifiers are encrypted before storage
  • Fully customizable search screen, complex AND/OR relations,  searches can be saved/retrieved
  • Electronic case record forms (ECRFs) can be displayed in the context of a study schedule or globally in a register view. Study-specific view includes status information
  • Complex right management per user, principal investigator can define roles / rights from within the application
  • Reduction of input errors by predefined inputs and data checks, free text only for comments
  • Audit Trail: Input and changes are tracked with log of user and date, compliant with GCP requirements. Change history can be displayed via web-interface
  • Sample management including full information on location and use history.
  • Export function (Excel or plain text) for data transfer to statistical software, parameter selection can be saved / retrieved for re-use
Person Search, CRF overview, Specimen data sheet, Audit Trail, Sample management, Data retrieval